Who else makes this device?

Name: AST (Sgot) Reagent Set
Brand: AST (Sgot) Reagent Set

Clinical Chemistry › Test SystemsNadh Oxidation/Nad Reduction, Ast/Sgot

AST (Sgot) Reagent Set

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart,…

Registry build 21.09.26

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart, skeletal muscle and kidneys. Diseases involving any of these tissues can lead to elevated levels of AST in serum. Following myocardial infarction, AST levels are elevated and reach a peak after 48 to 60 hours. Hepatobiliary diseases such as cirrhosis, metastatic carcinoma and viral hepatitis can show increased levels of AST. Other disorders which can lead to an elevated level of AST are muscular dystrophy, dermatomyositis, acute pancreatitis and infectious mononucleosis.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CIT
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for AST (Sgot) Reagent Set
Listed by	Clinical Diagnostic Solutions, Inc., United States
FDA product code	CIT
Device type	Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class	Class 2
Regulation	21 CFR 862.1100
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Record published	2016-10-12
Record revised	2023-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for AST (Sgot) Reagent Set
Catalogue number	Size	Per pack	Status
R1 x 500mL, R2 x 125mL		2	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	19
AST	Randox Laboratories Limited	10
JAS Diagnostics	Drew Scientific, Ltd.	7
Synermed®	Infrared Laboratory Systems LLC	7
Pointe Scientific, Inc.	Horiba Instruments Incorporated	5
AU	Beckman Coulter, Inc.	4
Architect	Abbott Ireland	4
Synchron	Beckman Coulter, Inc.	4
ACE	Alfa Wassermann	4
Architect	Abbott Medical	3
Alinity	Abbott Ireland	3
Architect	Abbott Laboratories	3

Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.